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Results For "Biologics-License-Application"

85 News Found

USFDA accepts dupilumab for priority review in adults with prurigo nodularis
Drug Approval | June 01, 2022

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved


Grand Opening of Kodiak Sciences’ bioconjugation facility
Biotech | May 19, 2022

Grand Opening of Kodiak Sciences’ bioconjugation facility

Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases


Amneal achieves second U.S. biosimilars approval with Alymsys
Drug Approval | April 18, 2022

Amneal achieves second U.S. biosimilars approval with Alymsys

Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022


USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19
News | April 04, 2022

USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19

If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients


USFDA seeks more analysis on Merck’s BLA for Vaxneuvance
Biotech | April 01, 2022

USFDA seeks more analysis on Merck’s BLA for Vaxneuvance

No new studies have been requested


Sanofi and IGM Biosciences team up to commercialise IgM antibody agonists
Biotech | March 30, 2022

Sanofi and IGM Biosciences team up to commercialise IgM antibody agonists

Companies to leverage proprietary IgM antibody technology platform to discover agonists against three oncology targets and three immunology/inflammation targets


USFDA approves EUA for second booster dose of Moderna
News | March 29, 2022

USFDA approves EUA for second booster dose of Moderna

50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age


Amneal enters U.S. biosimilars market with approval of Releukotm
Drug Approval | March 02, 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022


Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review
Biotech | March 01, 2022

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review

If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.


Daewoong Pharmaceutical posts strong financials in 2021
News | February 22, 2022

Daewoong Pharmaceutical posts strong financials in 2021

Daewoong delivered KRW 1.055 trillion in sales, KRW 95.5 billion in operating profit and KRW 40.5 billion in net profit.